Structure + Content
The CAS Regulatory Affairs in Life Sciences focuses on the regulations for medical devices, in vitro diagnostics, and medical software.
Objectives + Skills
Environment
Medical devices, in vitro diagnostic medical devices, and medical software are developed, manufactured, and marketed within a highly regulated environment. Their successful lifecycle management requires expertise in regulatory affairs, quality management, and risk management.
In this CAS, you develop an understanding of the applicable standards, regulations, and industry practices, and learn how regulatory affairs, quality management, and product development interact throughout the product lifecycle.
For a deeper understanding of pharmaceutical product regulations, we recommend the CAS Regulatory Affairs Pharma.
Career opportunities
Typical positions include Regulatory Affairs Specialist, Regulatory Affairs Manager, Regulatory Affairs Consultant, and Regulatory Compliance Specialist.
The knowledge gained in this CAS is also relevant for professionals working in product development, engineering, manufacturing, project management, and other functions involved in the development, market access, and lifecycle management of healthcare products. It enables you to communicate effectively across multidisciplinary teams and to contribute to regulatory compliance throughout the product lifecycle.
Depending on your professional background and experience, you may also support or assume responsibilities associated with the Person Responsible for Regulatory Compliance (PRRC) as defined in Article 15 of the EU Medical Device Regulation (MDR).
Education goals
Upon completion of the CAS, you will be able to:
- Apply the key regulatory requirements governing medical devices, in vitro diagnostic medical devices (IVDs), and medical software, including relevant frameworks in Switzerland, the European Union, and the United States.
- Establish and maintain compliant quality management and risk management processes, taking into account standards such as ISO 13485 and related regulatory requirements.
- Apply principles of design control, usability engineering, validation, and post-market activities to support the development, market access, and lifecycle management of medical devices.
- Evaluate regulatory, quality, and cybersecurity requirements for digital health technologies, connected medical devices, and medical software.
- Understand the fundamentals of artificial intelligence in the life sciences industry, including current applications, regulatory considerations, and how to turn Trustworthy AI principles into practice.
Testimonial
The continuing education program in Regulatory Affairs in Pharma and Life Sciences provides an excellent foundation for understanding global regulatory frameworks. It is helping me strengthen my expertise in regulatory affairs and bridge my prior experience in pharmacovigilance with new regulatory knowledge. It offers a perfect balance of academic and real-world learning.
